Human Research Ethics Flashcards
What is human research?
Human research is conducted with or about people, or their data or tissue.
What are examples of human research?
- Taking part in surveys, interviews or focus groups
- Undergoing psychological, physiological or medical testing or treatment
- Being observed by researchers
- Researchers having access to the participants’ personal documents or other materials
- The collection and use of participants’ body organs, tissues, fluids or exhaled breath
- Access to participants’ information as part of an existing published or unpublished source or database
What does beneficence and justice mean?
Beneficence: “do no harm” and maximise benefits while minimising harm to participants
Justice: ensuring that the burden of research does not fall unfairly on any individual or class of person
Who are the regulations governing human research ethics in Australia?
- National Statement on Ethical Conduct in Human Research (NHMRC)
- Australian Code for the Responsible Conduct of Research
- Curtin University’s Research Management Policy
- Curtin University’s Responsible Conduct of Research Policy
Why is human ethics approval necessary?
- To ensure protection of participants and researchers
- Research ethics is part of an institution’s responsibilities for research governance
- The NHMRC Act (1992) requires all research involving humans to be subject to ethical review
The key task of an ethics committee is to ensure research is conducted according to high ethical standards to … Provide 4 reasons
- Protect participants
- Protect researchers
- Ensure research merit & integrity
- Monitor research (governance)
To ensure participants’ welfare, the ethics committee reviews proposals for compliance with the core principles of the National Statement
What are the FOUR key principles of human research? What are some factors/advantages to consider for each one?
Respect for human beings
- Informed consent
- Cultural competence
- Privacy and confidentiality
Research merit and integrity
- Design and methodology
- Participatory approach
- Maintaining integrity
Justice
- Consideration for vulnerable Groups
- Equitable selection
- Dissemination of research
Beneficence
- Benefits to Participants
- Management of Risks
- Protection from Harm
What are some examples of responsibilities as a researcher?
- Maintain high standards of responsible research
- Report research responsibly
- Respect research participants
- Respect animals used in research
- Respect the environment
- Report research misconduct
- Designing the research to minimise the risks of harm or discomfort to participants
- Clarifying for participants the potential benefits and risks of the research
- The welfare of the participants in the research context
- Respect privacy, confidentiality and cultural sensitivities.
What is risk in human research? What are the types of risk? What is the spectrum of severity?
Risk is the potential for a negative outcome or effect of the researc
- types: physical, psychological, social, economic, legal and privacy
> Risks are considered to occur on a spectrum of severity from inconvenience to discomfort to harm
For risk categories in Human Research;
A) What is negligible risk?
B) What is low risk?
C) What is non-low risk?
A)
- Only foreseeable risk is no more than inconvenience
B)
- Only foreseeable risk is one of discomfort or inconvenience
C)
- The risk to participants is more serious than discomfort
- Must be reviewed by the HREC (Human Research Ethics Committee)
Who are the vulnerable populations for human research?
- Pregnant women and the human fetus
- People highly dependent on medical care who may not be able to give consent
- People with cognitive impairment, intellectual disability, or a mental illness
- People who may be involved in illegal activities
- Aboriginal and Torres Strait Islander peoples
What research types must be reviewed by the HREC ((Human Research Ethics Committee))?
- Research that involves active concealment or planned deception
- Research that aims to expose illegal activity
- Consent that involves an opt-out approach
- Waiver of consent for using health information
- Clinical trials
- Research that may reveal information that may be important for the health of the donor(s), their blood relatives or their community
- Genetic research
What are the types of applicants at curtin university (ethics)
- Preliminary classification of ethics applications
- Negligible risk applications
- Low-risk applications
- Non-low risk applications
- Human Research Ethics Committee review
What is a reciprocal application?
- If you have ethics approval from another institution you can submit a reciprocal application form
- If the approval is from an overseas institution you may still be able to receive reciprocal approval, you just need to explain the ethics process there
Submit
- The application form
- Any documents that were approved
- The approval letter
What are the common issues with ethics applications?
- Lay language is not used
- Data storage incorrect
- Not addressing dependent/unequal relationships
- Vague answers
- Don’t make reviewers have to work to find the answers
- Inconsistencies between the form and the protocol
